Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants
20 de agosto de 2026 actualizado por: WANG XINQIONG, Ruijin Hospital
A Multicenter, Randomized, Controlled Trial to Evaluate the Effects of Goat Milk Formula on Gastrointestinal Comfort, Behavioral Status, and Early Growth and Development in Infants
Infant gastrointestinal discomfort is common in early life and can affect feeding, sleep, and overall well-being. Goat milk formula, due to its unique protein composition and smaller fat globules, may be easier to digest and potentially improve gastrointestinal tolerance in infants.
This study is a multicenter, randomized, controlled trial designed to evaluate the effects of goat milk formula compared with standard cow milk formula in infants aged 0-5 months with gastrointestinal discomfort. The study will assess improvements in gastrointestinal symptoms, overall comfort, behavioral status, and early growth and development, as well as explore potential changes in gut microbiota and intestinal inflammation.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xinqiong Wang
- Número de teléfono: 021-64370045
- Correo electrónico: wangxq1983@126.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Infants aged 0 to 5 months at enrollment
- Full-term birth (gestational age ≥37 weeks)
- Birth weight ≥2500 g
- Infants with symptoms of gastrointestinal discomfort (e.g., abdominal distension, excessive crying, regurgitation, or feeding intolerance)
- Parents or legal guardians able and willing to provide written informed consent and comply with study procedures
Exclusion Criteria:
- Infants with known or suspected organic gastrointestinal diseases (e.g., congenital malformations, Hirschsprung disease)
- History of severe perinatal complications or significant systemic diseases
- Known or suspected cow's milk protein allergy or other food allergies
- Use of antibiotics, probiotics, or other medications that may affect gastrointestinal function within 2 weeks prior to enrollment
- Participation in another clinical study within the past 3 months
- Any condition that, in the investigator's judgment, may interfere with study participation or outcome assessment For the reference cohort: healthy breastfed infants without significant gastrointestinal symptoms
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Goat Milk Formula Group
Infants in this group will be fed with goat milk-based infant formula and receive feeding and care guidance during the study period.
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Infants will receive goat milk-based formula as their primary feeding during the intervention period, according to standard feeding practices.
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Comparador activo: Cow Milk Formula Group
Infants in this group will continue to receive standard cow milk-based infant formula and receive feeding and care guidance during the study period.
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Infants will receive standard cow milk-based formula as their primary feeding during the intervention period, according to routine feeding practices.
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Sin intervención: Healthy breastfeeding
No feeding intervention will be performed; only fecal samples and clinical data will be collected.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Response Rate Based on Infant Composite Comfort Score (ICCS) at Day 14
Periodo de tiempo: Baseline to Day 14
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The overall response rate is defined as the proportion of participants in each group showing a ≥30% improvement in ICCS from baseline to Day 14. ICCS is a composite measure combining gastrointestinal symptom burden and behavioral state, with total scores ranging from 0 to 30.
Higher scores indicate better overall comfort (better outcome).
Response is categorized as: Markedly Effective (improvement ≥50%), Effective (improvement ≥30% to <50%), and Ineffective (improvement <30% or worsening).
The overall response rate is calculated as (Markedly Effective + Effective) / Total Cases × 100%.
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Baseline to Day 14
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Gastrointestinal Symptom Burden Score
Periodo de tiempo: Baseline to Day 28
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Change in gastrointestinal symptom burden score from baseline to Day 28, assessed using the Infant Gastrointestinal Symptom Assessment Scale.
The scale ranges from 0 to 15, with higher scores indicating greater symptom burden (worse outcome).
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Baseline to Day 28
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Resolution Rate of Individual Gastrointestinal Symptoms
Periodo de tiempo: Day 28
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Proportion of infants with complete resolution of individual gastrointestinal symptoms (e.g., abdominal distension, crying, vomiting) by Day 28.
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Day 28
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Change in Daily Sleep Duration
Periodo de tiempo: Baseline to Day 28
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Change in total daily sleep duration (minutes) based on caregiver-recorded 24-hour infant behavior diary.
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Baseline to Day 28
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Change in Daily Awake and Content Time
Periodo de tiempo: Baseline to Day 28
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Change in total daily duration of awake and content state as reported by caregivers.
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Baseline to Day 28
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Change in Parent-Reported Infant Comfort/Feeding Experience
Periodo de tiempo: Baseline to Day 28
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Change from baseline to Day 28 in parent-reported infant comfort experience, assessed using the following instrument: Parenting Feeding and Nurturing Experience Questionnaire total score. This questionnaire consists of 5 items, each scored from 1 to 5, giving a total score range of 5 to 25. Higher scores indicate a more positive parenting and feeding experience (better outcome). |
Baseline to Day 28
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Change in Parent-Reported Infant Feeding Experience
Periodo de tiempo: Baseline to Day 28
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Change from baseline to Day 28 in parent-reported infant feeding experience, assessed using the following instrument: Visual Analogue Scale (VAS) scores for parent-perceived infant overall comfort, feeding smoothness, and maternal anxiety. Each VAS item ranges from 0 to 10. For all three items, higher scores indicate better outcomes (i.e., more comfort, smoother feeding, and less anxiety). |
Baseline to Day 28
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Change in Weight-for-Age Z-Score
Periodo de tiempo: Baseline to Day 28
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Change in weight-for-age Z-score from baseline to Day 28.
Weight is measured in kilograms (kg) using a calibrated electronic infant scale.
The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3.
Higher Z-scores indicate greater weight for age, generally reflecting better growth outcomes in this population.
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Baseline to Day 28
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Change in Head Circumference-for-Age Z-Score
Periodo de tiempo: Baseline to Day 28
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Change in head circumference-for-age Z-score from baseline to Day 28.
Head circumference is measured in centimeters (cm) using a non-stretchable measuring tape.
The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3.
Higher Z-scores indicate greater head circumference for age, reflecting appropriate brain and cranial growth.
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Baseline to Day 28
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Change in Length-for-Age Z-Score
Periodo de tiempo: Baseline to Day 28
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Change in length-for-age Z-score from baseline to Day 28.
Length is measured in centimeters (cm) using a standard infant length measurement board.
The Z-score is a continuous variable (standard deviation units relative to the WHO child growth standard), with a typical clinical range of -3 to +3.
Higher Z-scores indicate greater length for age, generally reflecting better growth outcomes in this population.
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Baseline to Day 28
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Changes in Gut Microbiota Composition
Periodo de tiempo: Baseline and Week 4
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Changes in gut microbiota composition, including relative abundance of key bacterial taxa, assessed by 16S rRNA sequencing of stool samples.
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Baseline and Week 4
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Change in Fecal Calprotectin Levels
Periodo de tiempo: Baseline and Week 4
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Change in fecal calprotectin concentration as a marker of intestinal inflammation.
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Baseline and Week 4
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
21 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GFC2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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